Beta-hydroxybutyrate to boost immunotherapy in multiple myeloma
BEAM-MM - β-Hydroxybutyrate-Enhanced Adaptive Immunity in Multiple Myeloma
This study will test whether raising blood beta-hydroxybutyrate with a ketogenic diet or oral ketone supplements can safely improve responses to CAR‑T or BCMA‑directed bispecific therapy in adults with multiple myeloma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Drugs / interventions | Teclistamab, Elranatamab, Linvoseltamab, CAR-T, immunotherapy |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT07564219 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial assigns adults with multiple myeloma who are planned for BCMA-targeted CAR‑T or a BCMA-directed bispecific antibody to one of four active interventions or to standard nutritional care. Active arms include a strict ketogenic diet (<10% calories from carbohydrates) or oral ketone monoester (deltaG®) given three times daily at either a low (40.5 g/day) or high (75 g/day) dose. The study will monitor blood beta-hydroxybutyrate levels, safety and tolerability, and measures of immunotherapy response to see if higher BHB levels correlate with improved immune activity and clinical outcomes. Key exclusions include active infections, prior immunoeffector therapy, significant recent weight loss, very high tumor burden with tumor lysis risk, and inability to exclude pregnancy.
Who should consider this trial
Good fit: Adults (≥18) with multiple myeloma who are scheduled to receive BCMA-targeted CAR‑T therapy or a BCMA-directed bispecific antibody and who are medically stable without active infection or contraindications to ketogenic approaches.
Not a fit: Patients with active systemic infections, known HIV or hepatitis, prior CAR‑T or bispecific therapy, significant recent weight loss, very high tumor burden at risk for tumor lysis, or who cannot tolerate a ketogenic diet or ketone supplements are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, raising BHB could make BCMA-directed immunotherapies work better and increase response rates and durability for people with multiple myeloma.
How similar studies have performed: Preclinical work and small human studies indicate ketogenic diets or exogenous ketones can alter immune function, but combining BHB elevation with CAR‑T or BCMA bispecific therapy is largely novel and unproven in larger clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Multiple Myeloma with indication for CAR-T cell therapy with Ciltacabtagene autoleucel (target antigen: BCMA) or a BCMA-directed bispecific antibody (e.g., Teclistamab, Elranatamab, Linvoseltamab). * Age ≥18 years on the day the informed consent is signed. Exclusion Criteria: * Active infection requiring systemic therapy. * Known history of infection with Human Immunodeficiency Virus (HIV) or Hepatitis. * Significant short-term weight loss (\>10% within the last 6 weeks). * ECOG Performance Status ≥2. * Prior immunoeffector cell therapy (CAR-T cell therapy or bispecific antibodies). * Active immunosuppression due to another condition (e.g., autoimmune disease, second malignancy). * Very high tumor burden with high risk for tumor lysis syndrome, as determined by myeloma-specific markers or markedly elevated LDH (per the treating myeloma team). * Women of childbearing potential in whom pregnancy cannot be reliably excluded prior to study entry.
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Joseph Tintelnot, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Jan Weller, MD
- Email: j.weller@uke.de
- Phone: 0049 40 7410 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.